Clinical Trial of Safety and Efficiency of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression

This study has been completed.

Sponsor:

Materia Medica Holding

ClinicalTrials.gov Identifier:

NCT01716104

First Posted: October 29, 2012

Last Update Posted: December 7, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Multicentric Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Safety and Efficiency of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Exacerbation or decompensation of chronic diseases affecting the possibility of patients to participate in the clinical trial, including severe concurrent cardiovascular conditions and disorders of the nervous system, renal and hepatic insufficiency.

History of administration of testosterone 5-alpha-reductase inhibitors (finasteride, dutasteride).

History of polyvalent allergy.

Allergy/intolerance to any component of drug agents used in the therapy.

Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency.

Administration of drugs specified as "Prohibited concomitant therapy", within 3 months before enrollment.

Exacerbation or decompensation of chronic diseases affecting the possibility of patients to participate in the clinical trial.

Patients, who, in the investigator's opinion, will fail to observe the requirements during the trial or adhere to the studied drug administration procedure.

Participation in other clinical trials within 3 months before enrolment in this trial.

Presence of other factors, complicating the patient's participation in the trial (e.g., planned lengthy business and other trips).

A patient is a part of the center's research staff, taking a direct part in the trial, or an immediate family member of the investigator. Immediate family members are defined as spouses, parents, children or siblings, regardless of whether full blood or adopted.

The patient is employed with Scientific Production Firm Materia Medica Holding LLC, i.e. is the company's employee, part-time employee under contract, or appointed official in charge of the trial, or their immediate family.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716104

Locations

Russian Federation

Limited liability company "Family Policlinic No. 4"

Moscow region Koroljov, Russian Federation, 141060

The State Budget Health Care institution of Moscow the City "Hospital for veterans of wars No. 2 of the Administration of Health Care of Moscow City"

Moscow, Russian Federation, 109472

The State Budget Health Care institution of Moscow the City "Specialized clinical (neuro-psychiatric) hospital No. 8 n.a. Z.P. Solovyov - ''Clinic of neuroses" of the Administration of Health Care of Moscow City

Moscow, Russian Federation, 115419

The Federal State Budget Educational institution of High Professional Training "Peoples' Friendship University of Russia", Department of Urology and Operative Nephrology

Moscow, Russian Federation, 117198

The State Budget Educational institution of High Professional Training I.M. Sechenov First Moscow State Medical University of Ministry of Health Care and Social Development of the Russian Federation, Department of Urology

Moscow, Russian Federation, 119991

The State Budgetary Educational Institution of Higher Professional Education " Moscow State University of Medicine and Dentistry of A. I. Evdokimov" Ministry of Health of the Russian Federation

Moscow, Russian Federation, 127473

The Federal State Budget institution "Polyclinic № 3" of Affairs Management Department of the President of the Russian Federation

The Federal State Budgetary Institution " Saint-Petersburg Research Institute Phthisiopulmonology " Ministry of Health of the Russian Federation

St. Petersburg, Russian Federation, 191036

The Federal State institution "All-Russian center of emergency and radiation medicine n.a. A.M. Nikiforov" of the Ministry of the Russian Federation for Affairs of civil defence, emergencies and elimination of consequences of natural disasters